A Phase III Multicenter, Double-Blind, Parallel-Group, Placebo Controlled Study to Measure the Effect of Riluzole 50 mg b.i.d. Over a Period of Three Years on the Progression of Huntington's Disease

Brief Summary

Primary objective:

The primary objective of the study is to establish that riluzole slows down (1) the decrease in total functional capacity (TFC), (2) the increase of the motor score of the Unified Huntington's Disease Rating Scale (UHDRS) as well as (3) the increase of a combined score of these.

Secondary objectives:

Secondary objectives are to assess

changes in the other UHDRS subscales

the number of patients who need antichoreic treatment and the time until this treatment has to be initiated

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

537

Completion Date

July 2004

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Clinical diagnosis of Huntington's disease and CAG repeat length of 36 or more

UHDRS Motor score of at least 5 points

UHDRS TFC score of at least 8 points, i.e. patients must be independently ambulatory and must not require nursing care

Females require a negative blood pregnancy test at inclusion

Exclusion Criteria:

Any forms of chorea other than Huntington's disease

Patients on antichoreic treatment within one month prior to entry or foreseen to require such treatment within the first 3 months after randomization (antichoreic medication is prohibited during entire study)